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they provide. The economic value of such knowledge or information may derive from the intellectual property rights that could be generated by or claimed on such knowledge or information. Intellectual property rights Intellectual property rights (IPR) confer protection on the creators of knowledge or information by giving them property rights over the results of their creative or intellectual efforts. Such property rights relate to the items of information or knowledge that can be incorporated in tangible objects in an unlimited number of copies (and not to those objects or copies as such). IPR are usually divided into two categories: (1) industrial property, which includes patents for inventions, trademarks and industrial designs; and (2) copyright, which includes literary and artistic creations such as books and films as well as technology-based works such as computer programs and databases. IPR are usually also subject to certain limitations, such as a limited duration in time in the case of copyright and patents. While IPRs invariably play an important role throughout the Blue Biotechnology development and marketing cycle (in terms, for example, of the trademark protection of biotech products) in terms of ABS the most relevant IPR are copyright/database rights and patents. Intellectual property (IP) law is a complex area of law which derives primarily from national legislation although as will be seen a number of international instruments seek to harmonise approaches to IPR and their cross-border recognition and treatment. It follows that IP legislation varies from country to country in accordance with the applicable national IP policy (which may in turn vary from time to time reflecting technical and economic priorities). Within the EU a certain amount of harmonization has been achieved through the introduction of the unitary patent regime as well as specific legislation on copyright/database rights both of which are considered in more detail below. At the level of international law the principal international organisation concerned with IP issues is the World Intellectual Property Organisation (WIPO), which administers a number of international agreements concerned with IP. Moreover, mention must be made of the Trade-Related Aspects of Intellectual Property Rights Agreement280 (TRIPS) concluded under the auspices of the World Trade Organisation (WTO). TRIPS requires States that are members of the WTO to provide minimum standards of protection of a wide range of IPRs. Copyright/database rights The relevance of copyright/database rights to Blue Biotechnology arises as follows. The analysis and assessment of the genetic capabilities of marine organisms involves the sequencing of their genome and annotation of the genes. This process of genomic and metagenomic analyses coupled with deep sequencing generates large datasets from resources acquired from marine environments. Specific bioinformatics resources and tools have been developed in order to try and maximize the capacity to analyze the resulting vast datasets. Such datasets are subject to, and protected by, copyright. The same may be true for the tools (e.g. computer programs) that are developed to generate, analyse or otherwise process these datasets. Copyright arises automatically and without formality upon creation of the work, generally once it is fixed in some material (reproducible) form. Databases (in any form) can also benefit from copyright protection. Copyright protection will be accorded to databases that ‘by reason of the selection or arrangement of their contents’ constitute the author’s own intellectual creation281 280 Annex 1C to the Agreement establishing the WTO (Marrakesh, 15 April 1994). 281 Article 3 (1) of the Database Directive. (i.e. concept of Study in support of Impact Assessment work on Blue Biotechnology 203

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